united states environmental protection ......2011/12/29  · united states environmental protection...

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460-0001 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION December 29, 2011 Nasser A. Assaf, Ph.D Manager, Product Safety & Regulatory Affairs Valent BioSciences Corporation 870 Technology Way Libertyville, IL 60048 Subject: Amended Reregistration Label Product Name: PYRAPERM® Total Release Indoor Fogger WBA P61 EPA Registration Number: 73049-348 EPA Decision Numbers: 410084, 411554, 413107, and 458900 (fogger mitigation) Dear Dr. Assaf: The Agency, in accordance with the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), as amended, has completed reviewing all of the information submitted with your application to support the reregistration of the above referenced product in connection with the Permethrin, Pyrethrins, and Piperonyl Butoxide REDs, and has concluded that your submission is acceptable. NOTE: This product is not being reregistered under sections 3(c)5 and 4(g) of FIFRA at this time. Please be reminded that 40 CFRPart 156.140(a)(4) requires that a batch code, lot number, or other code identifying the batch of the pesticide distributed and sold be placed on non-refillable containers. The code may appear either on the label or durably marked on the container itself, and can be added by non-notification per PRN98-10. Please note that the record for this product currently contains the Confidential Statements of Formulation (CSFs) listed below. Any previously dated CSFs are superseded. - Basic CSF, dated 15 April, 2010 - Alternate CSF, dated 15 April, 2010 Page 1 of 2

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Page 1: UNITED STATES ENVIRONMENTAL PROTECTION ......2011/12/29  · UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460-0001 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

UNITED STATES ENVIRONMENTAL PROTECTION AGENCYWASHINGTON, D.C. 20460-0001

OFFICE OF CHEMICAL SAFETYAND POLLUTION PREVENTION

December 29, 2011

Nasser A. Assaf, Ph.DManager, Product Safety & Regulatory AffairsValent BioSciences Corporation870 Technology WayLibertyville, IL 60048

Subject: Amended Reregistration LabelProduct Name: PYRAPERM® Total Release Indoor Fogger WBA P61EPA Registration Number: 73049-348EPA Decision Numbers: 410084, 411554, 413107, and 458900 (foggermitigation)

Dear Dr. Assaf:

The Agency, in accordance with the Federal Insecticide, Fungicide and Rodenticide Act(FIFRA), as amended, has completed reviewing all of the information submitted with yourapplication to support the reregistration of the above referenced product in connection withthe Permethrin, Pyrethrins, and Piperonyl Butoxide REDs, and has concluded that yoursubmission is acceptable.

NOTE: This product is not being reregistered under sections 3(c)5 and 4(g) of FIFRA at thistime.

Please be reminded that 40 CFR Part 156.140(a)(4) requires that a batch code, lotnumber, or other code identifying the batch of the pesticide distributed and sold be placed onnon-refillable containers. The code may appear either on the label or durably marked on thecontainer itself, and can be added by non-notification per PRN 98-10.

Please note that the record for this product currently contains the ConfidentialStatements of Formulation (CSFs) listed below. Any previously dated CSFs are superseded.

- Basic CSF, dated 15 April, 2010- Alternate CSF, dated 15 April, 2010

Page 1 of 2

Page 2: UNITED STATES ENVIRONMENTAL PROTECTION ......2011/12/29  · UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460-0001 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

A copy of your label stamped "Accepted" is enclosed along with copies of the acutetoxicity and product chemistry reviews completed for the subject product. Products shippedafter 12 months from the date of this amendment or the next printing of the label whicheveroccurs first, must bear the new revised label. Your release for shipment of the product bearingthe amended label constitutes acceptance of these conditions. If these conditions are notcomplied with, the registration will be subject to cancellation in accordance with FIFRA sec.6(e).

If you have any questions about this letter, please contact Clayton Myers at 703-347-8874 or [email protected].

Sincerely,

Richard J. GebkenProduct ManagerInsecticide BranchRegistration Division (7505P)

Enclosures: Label stamped "Accepted," dated December 29, 2011Acute Toxicity Review, dated January 6, 2011Product Chemistry Review, dated August 16, 2011

Page 2 of 2

Page 3: UNITED STATES ENVIRONMENTAL PROTECTION ......2011/12/29  · UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460-0001 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

73049-348 Master Label December 20, 2011Page 1 of6

PYRAPERM®TOTAL RELEASE INDOOR FOGGER WBA P61• [Contains Pyrenone® And Permanone®• Seeks Out Bugs Where They Hide• Kills On Contact• Non-Staining• Wo Unpleasant Odor• Water-Based Formula• Kills Exposed Or Accessible Stages Of These Insects: Ants, Booklice, Carpet Beetles,

Centipedes, Cockroaches, Confused Flour Beetles, Crickets, Earwigs, Firebrats, Fleas (AdultsAnd Larvae), Flies, Fruit Flies, Gnats, Grasshoppers, Hornets, Houseflies, Midges, Millipedes,Mole Crickets, Mosquitoes, Palmetto Bugs, Pillbugs, Rice Weevils, Saw-Toothed Grain Beetles,Scorpions, Silverfish, Small Flying Moths, Sowbugs, Spiders, Stable Flies (Dog Flies), Ticks(Including Those Which May Cause Lyme Disease), Wasps, Waterbugs And Yellow Jackets]

{The entire label is printed in Spanish language [inside/outside the box][on peel out booklet] [orinsert]}.

ACTIVE INGREDIENTS:Pyrethrins 0.2%Piperonyl Butoxide* 1.0%Permethrin** 0.4%OTHER INGREDIENTSt: 98.4%

100.0%

* (butyl carbityl)(6-propylpiperonyl) ether and related compounds.**Cis/trans ratio: min. 35% (+/-) cis and max. 65% (+/-) trans.•(•Contains Petroleum Distillate

DEC 2 9 2011

Aitfee pesticide

7Jo«/1 - 3?*

PRECAUCION AL CONSUMIDOR: Si usted no lee ingles, no use este producto hasta que la etiqueta lehaya sido explicada amplimente.(TO THE USER: If you cannot read English, do not use this product until the label has been fully explainedto you.)

EPA REG. NO. 73049-348 EPA EST. NO.

KEEP OUT OF REACH OF CHILDREN

CAUTIONSee Side/Back Panel For Additional Precautions

If Swallowed:

FIRST AID

Immediately call a poison control center or doctor.Do not induce vomiting unless told to do so by a poison control center or doctor.Do not give any liquid to the person.Do not give anything by mouth to an unconscious person.

HOT LINE NUMBER

Have the product container or label with you when calling a poison control center or doctor, or going for treatment Foradditional information on this product (including health concerns, medical emergencies or pesticide incidents), you maycall 1-877-315-9819.

NOTE TO PHYSICIAN

Contains petroleum distillate - vomiting may cause aspiration pneumonia.

NET WEIGHT:

Page 4: UNITED STATES ENVIRONMENTAL PROTECTION ......2011/12/29  · UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460-0001 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

noes73049-348 Master Label December 20, 2011

Page 2 of 6

PRECAUTIONARY STATEMENTSHazards To Humans & Domestic Animals

CAUTIONHarmful if swallowed. Breathing spray mist may be harmful. Wash thoroughly with soap and water afterhandling and before eating, drinking, chewing gum, using tobacco, or using the toilet. Remove and washcontaminated clothing before reuse.

[Alternate text required for professional use products][PERSONAL PROTECTIVE EQUIPMENT (PPE)

Applicators and other handlers, must wear the following:• Long-sleeved shirt• Long pants• Shoes plus socks

User Safety Recommendations:• Users should remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly

and put on clean clothing.• Follow manufacturer's instructions for cleaning/maintaining PPE. If there are no such instructions

for washables, use detergent and hot water. Keep and wash PPE separately from other laundry. ]

Physical and Chemical HazardsContents under pressure. Do not use or store near heat or open flame. Do not puncture or incineratecontainer. Do not place on stove or radiator. Exposure to temperatures above 130°F may cause bursting.This product contains a highly flammable ingredient. It may cause a fire or explosion if not used properly.Follow the Directions for Use on this label very carefully.

Highly Flammable IngredientIngrediente Altamente Inflamable

DIRECTIONS FOR USEIt is a violation of Federal law to use this product in a manner inconsistent with its labeling.

Use Restrictions• Do not remain in treated area. Exit area immediately and do not re-enter or allow adults,

children, or pets to enter until vapors, and/or mist have dispersed and the treated area hasbeen thoroughly ventilated.

• Wait two (2) hours after application, then open windows, vents and doors for two hours. Thereshould be no remaining trace of pesticide fog or aerosol. If an odor is still detected additionalventilation is required.

• Do not apply this product in a way that will contact adults, children, or pets, either directly orthrough drift.

• Do not apply when food is present. Exposed food should be covered or removed. All foodpreparation surfaces and utensils should be covered during treatment or thoroughly washedbefore use.

• Do not use in greenhouses where plants are grown for food.• Remove pets, birds and cover any water inhabited by fish (such as aquariums and ornamental

fish ponds) before application. Turn off aquarium filtering systems before spraying and waitapproximately 15 minutes after application before turning the filter back on.

• Do not contaminate animal feed or water during application.• [Alternate text: When used in dairy barns or facilities: Close milk bulk tank lids to prevent

contamination from dead or falling insects. Remove or cover milking utensils beforeapplication. Wash teats of animals before milking.]

[Alternate Use Restrictions for - Professional Use Labeling:]• [Do not remain in treated area. Exit area immediately and do not re-enter or allow adults,

children, or pets to enter until vapors, and/or mist have dispersed and the treated area hasbeen thoroughly ventilated.

• Do not apply this product in a way that will contact workers or other persons, either directly orthrough drift.

Page 5: UNITED STATES ENVIRONMENTAL PROTECTION ......2011/12/29  · UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460-0001 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

73049-348 Master Label December 20, 2011Page 3 of6

• Wait two (2) hours after application, then open windows, vents and doors for two (2) hours.There should be no remaining trace of pesticide fog or aerosol. If an odor is still detected,continue ventilating until no remaining trace or odor of pesticide remains.

• Do not apply when food is present. Exposed food should be covered or removed. All foodpreparation surfaces and utensils should be covered during treatment or thoroughly washedbefore use.

• Do not use in greenhouses where plants are grown for food.• Do not use in food areas of food handling establishments, restaurants, or other areas where

food is commercially prepared or processed. Do not use in serving areas while food is exposedor facility is in operation. Serving areas are areas where prepared foods are served, such asdining rooms, but excluding areas where foods may be prepared or held.

• May be applied in non-food/feed areas. Non-food/feed establishment areas are areas such asgarbage rooms, lavatories, entries and vestibules, offices, locker rooms, machine rooms, boilerrooms, mop closets and storage (after canning or bottling).

• Commercial food/feed areas where the product cannot be used include areas for receiving,serving, storage (Dry, Cold, Frozen, Raw), packaging (Cleaning, Slicing, Cooking, Grinding),edible, waste storage, enclosed processing systems (Mills, Dairies, Edible Oils, Syrups).

• Do not use in aircraft cabins.• Remove pets, birds and cover any water inhabited by fish (such as aquariums and ornamental

fish ponds) before application. Turn off aquarium filtering systems before spraying and waitapproximately 15 minutes after application before turning the filter back on.

• Remove poultry before treating poultry houses.• When used in dairy barns or facilities: Close milk bulk tank lids to prevent contamination from

dead or falling insects. Remove or cover milking utensils before application. Wash teats ofanimals before milking.]

For use in apartments, attics, basements, boats, cabins, campers, closed barns, day camps, garages,homes, horse stables, household storage areas, kennels, pet sleeping areas, rooms, non-commercialgreenhouses, ship cabins, lathouses, seed houses, washrooms and the non-food/feed areas of schools,theaters, trucks, warehouses, boxcars, hospitals, hotels, industrial plants, motels and preschools.

[One 2 ounce aerosol can treats up to 2,000 cubic feet of unobstructed area (a room 10= x 25= with an 8foot ceiling).][To calculate cubic feet, multiply height x width x length.]

For Fleas and Ticks, use one 2 ounce can for every 2,000 cubic feet of room space.

Does not control bed bugs.

HOW TO USE:

{graphic size2.25 cm x 3.5cm minimum}

{graphic size2.25 cm x 3.5cm minimum}

{graphic size2.25 cm x 3.5cm minimum}

To use this product correctly:

DO NOT use multiple canisters in a room.

DO NOT use in small, enclosed spaces such as closets,cabinets or under counters or tables. Use of a fogger in anenclosed space may cause the product to explode, resulting ininjury to people or damage to property. Do not use in a room 5ft. x 5 ft. or smaller; instead, allow fog to enter from otherrooms.

[Step 1:] BEFORE YOU FOG:REMOVE or cover exposed foods, dishes, utensils, foodprocessing equipment and surfaces. OPEN cabinets,cupboards, trunks, drawers, closets and doors in area to betreated to allow maximum kill in all areas where insects canhide and breed. Cover waxed wood floors, waxed furniture andother plastic surfaces near the fogger (newspaper may beused). CLOSE outside doors and windows to maximize killingpower of fog. Cover or remove plants. SHUT OFF fans and airconditioners.

Page 6: UNITED STATES ENVIRONMENTAL PROTECTION ......2011/12/29  · UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460-0001 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

73049-348 Master Label

{graphic size2.25 cm x 3.5cm minimum}

{graphic size2.25 cm x 4 cmminimum}

{graphic size2.25 cm x 3.5cm minimum}

December 20, 2011Page 4 of 6

Turn off ALL ignition sources such as pilot lights (shut offgas valves), other open flames or running electricalappliances that cycle off and on (i.e., refrigerators,thermostats, etc). Call your gas utility or managementcompany if you need assistance.

[Step 2:] TO START FOGGING:SHAKE WELL JUST BEFORE USING. Do not place on waterstainable surface. Place a chair or table in the center of area tobe fogged approximately 2 ft above the floor. Cover withseveral layers of newspaper or paper towels. Tilt can openingAWAY from face and depress tab firmly with thumb until itclicks in locked position. Set fogger on newspaper. Vacate thetreated house, individual apartment unit, or other structureimmediately. Do not re-enter for 2 hours. [Fill out and placehang-tag on the door to the treated area to alert family andothers with access to the treated area not to enter for 2 hours.]

[Step 3:] AIRING OUT:Before reoccupying the area, open all doors and windows andallow treated area to air for two (2) hours.

STORAGE AND DISPOSALDo not contaminate water, food or feed by storage or disposal.Pesticide Storage: Store in a cool, dry area inaccessible to children and pets and away from heat, sparksor open flame.Pesticide Disposal and Container Handling: Do Not Puncture or Incinerate! If empty: Place in trash oroffer for recycling if available.If partly filled: Call your local solid waste agency for disposal instructions.[This container may be recycled in aerosol recycling centers. At present, there are only a few such centersin the country. Before offering for recycling, empty the can by using the product according to the label.]

IMPORTANT: READ BEFORE USERead the entire Directions for Use, Conditions, Disclaimer of Warranties and Limitations of Liability beforeusing this product. If terms are not acceptable, return the unopened product container at once.By using this product, user or buyer accepts the following conditions, disclaimer of warranties andlimitations of liability.CONDITIONS: The directions for use of this product are believed to be adequate and must be followedcarefully. However, it is impossible to eliminate all risks associated with the use of this product.Ineffectiveness or other unintended consequences may result because of such factors as weatherconditions, presence of other materials, or the manner of use or application, all of which are beyond thecontrol of Valent BioSciences Corporation. All such risks shall be assumed by the user or buyer.DISCLAIMER OF WARRANTIES: TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, VALENTBIOSCIENCES CORPORATION MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, OFMERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE OR OTHERWISE, THAT EXTENDBEYOND THE STATEMENTS MADE ON THIS LABEL. No agent of Valent BioSciences Corporation isauthorized to make any warranties beyond those contained herein or to modify the warranties containedherein. To the extent consistent with applicable law, Valent BioSciences Corporation disclaims any liabilitywhatsoever for special, incidental or consequential damages resulting from the use or handling of thisproduct.LIMITATIONS OF LIABILITY: TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, THEEXCLUSIVE REMEDY OF THE USER OR BUYER FOR ANY AND ALL LOSSES, INJURIES ORDAMAGES RESULTING FROM THE USE OR HANDLING OF THIS PRODUCT, WHETHER INCONTRACT, WARRANTY, TORT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE, SHALL NOTEXCEED THE PURCHASE PRICE PAID, OR AT VALENT BIOSCIENCES CORPORATION'S ELECTION,THE REPLACEMENT OF PRODUCT.

Page 7: UNITED STATES ENVIRONMENTAL PROTECTION ......2011/12/29  · UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460-0001 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

73049-348 Master Label December 20,2011Page 5 of6

[Or alternate textNote [Notice]: Seller warrants that this product complies with the specifications expressed in this label. Tothe extent consistent with applicable law, seller makes no other warranties, and disclaims all otherwarranties, express or implied, including but not limited to warranties of merchantability and fitness for theintended purpose. To the extent consistent with applicable law, seller's liability or default, breach or failureunder this label shall be limited to the amount of the purchase price. To the extent consistent withapplicable law, seller shall have no liability for consequential damages.

OrNotice: to the extent consistent with applicable law, buyer assumes all responsibility for safety and use notin accordance with directions.]

©Valent BioSciences Corporation, 2011

PyraPerm is a registered trademark of Valent BioSciences Corporation.Pyrenone and Permanone are registered trademarks of Bayer AG.

Valent BioSciences CorporationEnvironmental Science Division870 Technology WayLibertyville, IL 60048

{TEXT ON DOOR KNOB HAND TAG}

[Attention:] [Notice:] Fogger In Use

[Area has been treated with [PyraPerm Total Release Indoor Fogger WBA P61] [Fogger.]

Note to User: Fill out and place hang-tag on the door to the treated area to alert family and others with accessto the treated area not to enter for 2 hours.

[Do not enter [re-enter] treated [house] [apartment] [premises] until AM/PM on date]

[Do not return to [enter] treated premises for 2 hours [until 2 hours have expired AM/PM [day]]

[Air out the room] [Wait 2 hours after application, then open windows, vents and doors if an odor is stilldetectable.]

Area may begin airing out at: on_(time-2 hours after activation) (date)

Area may be re-entered after airing out time: on(2 hours minimum)

[cut here [scissors illustration] and hang on your door]

{TEXT ON CAN)

PyraPerm Total Release Indoor Fogger WBA P61

ACTIVE INGREDIENTS:Pyrethrins 0.2%Piperonyl Butoxide* 1.0%Permethrin** 0.4%OTHER INGREDIENTSt: 98.4%

100.0%* (butyl carbityl)(6-propylpiperonyl) ether and related compounds.**Cis/trans ratio: min. 35% (+/-) cis and max. 65% (+/-) trans.•(•Contains Petroleum Distillate

Page 8: UNITED STATES ENVIRONMENTAL PROTECTION ......2011/12/29  · UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460-0001 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

73049-348 Master Label December 20, 2011Page 6 of 6

KEEP OUT OF REACH OF CHILDRENCAUTION

See back panel [insert inside cap] [insert inside box] [hang tag] [outside/inside box [carton] [peel outbooklet] for complete directions for use, precautionary statements and first aid

[Available in English and Spanish][The entire label is [available] printed in Spanish [language] [inside the box] [on insert [found] [located]

[inside cap] [inside box] [on hang tag] [on peel out booklet]

STORAGE AND DISPOSALDo not contaminate water, food or feed by storage or disposal.Pesticide Storage: Store in a cool, dry area inaccessible to children and pets and away from heat, sparksor open flame.Pesticide Disposal and Container Handling: Do Not Puncture or Incinerate! If empty:Place in trash or offer for recycling if available. If partly filled: Call your local solid waste agency fordisposal instructions.

PRECAUTIONARY STATEMENTSHazards To Humans & Domestic Animals

CAUTIONHarmful if swallowed. Breathing spray mist may be harmful. Wash thoroughly with soap and water afterhandling and before eating, drinking, chewing gum, using tobacco, or using the toilet. Remove and washcontaminated clothing before reuse.

FIRST AID

If Swallowed: Immediately call a poison control center or doctor.Do not induce vomiting unless told to do so by a poison control center or doctor.Do not give any liquid to the person.Do not give anything by mouth to an unconscious person.

HOT LINE NUMBER

Have the product container or label with you when calling a poison control center or doctor, or going fortreatment For additional information on this product (including health concerns, medical emergencies orpesticide incidents), you may call 1-877-315-9819.

NOTE TO PHYSICIAN

Contains petroleum distillate - vomiting may cause aspiration pneumonia.

Physical And Chemical HazardsContents under pressure. Do not use or store near heat or open flame. Do not puncture or incineratecontainer. Do not place on stove or radiator. Exposure to temperatures above 130°F may cause bursting.Do not use this unit in less than 100 cubic feet. This product contains a highly flammable ingredient. It maycause a fire or explosion if not used properly. Follow the Directions for Use on this label very carefully.

Highly Flammable IngredientIngrediente Altamente Inflamable

Valent BioSciences CorporationEnvironmental Science Division870 Technology WayLibertyville, IL 60048

EPA Reg. No: 73049-34fcEPA Est. No:

NET Wt::

[Questions? Comments? See code on the bottom of can then call (xxx) xxx-xxxx or E-mail [email protected]]

{Additional information from the stamped accepted label may be provided on the can as space allows.}

[ ] denote alternate text in addition to any subset of the directions for use